Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:10 - 25
Updated:6/28/2018
Start Date:August 19, 2010
End Date:July 29, 2011

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Immunogenicity and Safety Study of One Dose of GSK Biologicals' Meningococcal Vaccine GSK 134612 (Blinded Lots) Versus One Dose of Menactra® in Healthy Subjects Aged 10-25 Years

The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK
Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through
25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK
134612 vaccine.


Inclusion Criteria:

All subjects must satisfy ALL of the following criteria at study entry:

- Subjects whom the investigator believes that they and/or their parent(s)/Legally
Acceptable Representative(s) can and will comply with the requirements of the
protocol.

- A male or female between, and including, 10 and 25 years of age at the time of the
vaccination.

- Written informed consent obtained from the subject/from the parent or Legally
Acceptable Representative(s) of the subject. Assent will be obtained from subjects who
are still legally minors in line with local rules and regulations.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Previously completed routine childhood vaccinations to the best of subject's/Legally
Acceptable Representative(s)'s knowledge.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Female subjects of childbearing potential may be enrolled in the study, if the
subject:

- has practiced adequate contraception for 30 days prior to vaccination, and

- has a negative pregnancy test on the day of vaccination, and

- has agreed to continue adequate contraception for 2 months after vaccination.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion
criterion applies, the subject must not be included in the study:

- Use of any investigational or non-registered product other than the study vaccine(s)
within 30 days preceding the dose of study vaccine, or planned use during the study
period.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to vaccination. (For corticosteroids,
this will mean prednisone <10 mg/day, or equivalent, is allowed. Inhaled and topical
steroids are allowed.)

- Planned administration/administration of a vaccine not foreseen by the study protocol
within one month of the dose of vaccine, with the exception of any licensed
inactivated influenza vaccine.

- Previous vaccination with meningococcal polysaccharide or conjugate vaccine.

- Previous vaccination with vaccine components within the last month.

- History of meningococcal disease.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus infection, based on medical history and physical
examination.

- A family history of congenital or hereditary immunodeficiency, until the immune
competence of the potential vaccine recipient is demonstrated.

- History of allergic reactions or disease likely to be exacerbated by any component of
either vaccine, or by dry natural rubber latex.

- History of any neurologic disorders, including Guillain-Barré Syndrome.

- Major congenital defects or serious chronic illness.

- Acute disease at the time of enrollment.

- Administration of immunoglobulins and/or any blood products within the three months
preceding the dose of study vaccine or planned administration during the study period.

- Pregnant or lactating female.

- History of chronic alcohol consumption and/or drug abuse.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.

- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.

- Child in care.

- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product.
We found this trial at
23
sites
Saint Louis, Missouri 63110
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Saint Louis, MO
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Albany, Oregon 97322
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Albany, OR
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Austin, Texas 78705
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Austin, TX
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Carnegie, Pennsylvania 15106
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Carnegie, PA
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Chandler, Arizona 85224
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Chandler, AZ
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Columbia, Maryland 21044
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Columbia, MD
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Coquitlam, British Columbia
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Coquitlam,
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Erie, Pennsylvania 16507
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Erie, PA
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Greer, South Carolina 29651
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Greer, SC
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Hermitage, Pennsylvania 16148
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Hermitage, PA
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Lexington, Kentucky 40504
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Lexington, KY
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Longmont, Colorado 80501
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Longmont, CO
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Marietta, Georgia 30060
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Marietta, GA
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Nicholasville, Kentucky 40356
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Nicholasville, KY
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Paramount, California 90723
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Paramount, CA
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Sacramento, California 95815
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Sacramento, CA
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Santa Rosa, California 95403
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Santa Rosa, CA
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Simpsonville, South Carolina 29681
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Simpsonville, SC
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Stevensville, Michigan 49127
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Stevensville, MI
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Stockbridge, Georgia 30281
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Stockbridge, GA
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Syracuse, New York 13210
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Syracuse, NY
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Wichita, Kansas 67207
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Wichita, KS
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Woodstock, Georgia 30189
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Woodstock, GA
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